This trial is active, not recruiting.

Condition melanoma (skin)
Treatments filgrastim, therapeutic autologous dendritic cells
Phase phase 1
Sponsor Baylor Health Care System
Collaborator National Cancer Institute (NCI)
Start date April 2001
Trial identifier NCT00017355, BAYUMC-000048, CDR0000068680, NCI-4170


RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 21 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed metastatic melanoma - HLA-A2-01 phenotype - Measurable disease - No active CNS or hepatic metastases PATIENT CHARACTERISTICS: Age: - 21 and over Performance status: - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - See Disease Characteristics - No viral hepatitis Renal: - Not specified Cardiovascular: - No prior venous thrombosis, angina pectoris, or congestive heart failure - Lactate dehydrogenase less than 2 times normal Pulmonary: - No prior asthma Immunologic: - Intradermal skin test positivity to mumps, Candida, or streptokinase antigen - No known sensitivity to E. coli drug preparations - No prior allergy to influenza vaccine - No active infection - No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis) Other: - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 8 weeks since prior interleukin-2 - At least 4 weeks since prior interferon alfa Chemotherapy: - At least 8 weeks since prior chemotherapy Endocrine therapy: - At least 2 weeks since prior corticosteroids - No concurrent corticosteroids Radiotherapy: - Not specified Surgery: - Not specified Other: - No concurrent immunosuppressive agents - At least 2 weeks since prior immunosuppressive agents

Additional Information

Official title Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial
Description OBJECTIVES: - Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma. - Determine the longevity of melanoma-specific immunity in patients treated with this regimen. - Perform serial analysis of T-cell and B-cell function in patients treated with this regimen. OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-6 or 1-7. Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells (PBMC). PBMC are processed for CD34+ cell isolation. These autologous CD34+ hematopoietic progenitor cells are cultured to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens (MART-1:27-35, gp100:209-217, and MAGE-3). Antigen-pulsed DC are incubated with interferon alfa to induce DC maturation. Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8 weeks. Treatment repeats at 2, 3, 4, and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression. Patients are followed at 2 and 4 weeks and then every 3 months for 1.5 years. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).